Endotracheal tube with dedicated evacuation port

ABSTRACT

Various embodiments of a tracheal tube capable of suctioning accumulated mucus secretions from the airway of intubated patients are provided. Disclosed embodiments include a variety of endotracheal tubes with integral suction lumens terminating in ports optimally located at the distal end of the endotracheal tubes between a Murphy&#39;s Eye and a cuff. During intubation, the foregoing features, among others, of the tracheal tube may have the effect of preventing bacterial colonization of the respiratory airway and the subsequent development of ventilator associated pneumonia (VAP) in the lungs.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.13/866,977, entitled “ENDOTRACHEAL TUBE WITH DEDICATED EVACUATION PORT”,filed Apr. 19, 2014, which is a continuation of U.S. Pat. No. 8,434,488,filed Jun. 8, 2009, which are herein incorporated by reference.

BACKGROUND

The present disclosure relates generally to medical devices and, moreparticularly, to airway devices, such as tracheal tubes.

This section is intended to introduce the reader to aspects of art thatmay be related to various aspects of the present disclosure, which aredescribed and/or claimed below. This discussion is believed to behelpful in providing the reader with background information tofacilitate a better understanding of the various aspects of the presentdisclosure. Accordingly, it should be understood that these statementsare to be read in this light, and not as admissions of prior art.

Endotracheal tubes are often placed in the airway of a patient inmedical situations that necessitate protection of the airway frompossible obstruction or occlusion. For instance, tracheal tubes may beused in emergency situations, such as when a patient experiences cardiacor respiratory arrest. Such intubations increase a patient's risk ofdeveloping ventilator-associated pneumonia (VAP) due to bacterialcolonization of the lower respiratory airways. In healthy individuals,mucociliary clearance removes particles and microorganisms, which helpsprevent respiratory infection. However, in critically ill patients,clearance mechanisms are compromised due to tracheal tube cuffinflation, and mucus accumulates at the distal end of the tracheal tubebelow the cuff. In many instances, such critically ill patients mayremain intubated for extensive periods of time, during which mucusaccumulated at the bottom of the cuff may drop to the proximal tracheaand ultimately infect the lungs.

In many instances, it may be desirable to manage the accumulation ofmucus secretions around the cuff via removal through externalsuctioning, administration of antibiotics, or a combination thereof Someendotracheal tubes exclusively target mucus secretions accumulated inthe area above the cuff. However, these systems fail to adequatelyaddress the accumulation of mucus secretions below the cuff.Additionally, traditional designs often include further drawbacks, suchas requirements for the assembly and addition of supplementary partsthat are not integral to the tracheal tube.

BRIEF DESCRIPTION OF THE DRAWINGS

Advantages of the present disclosure may become apparent upon readingthe following detailed description and upon reference to the drawings inwhich:

FIG. 1 is an elevational view of an exemplary endotracheal tube with asingle port located below a cuff in accordance with aspects of thepresent disclosure;

FIG. 2 is an elevational view of the distal end of the exemplaryendotracheal tube of FIG. 1 in accordance with aspects of the presentdisclosure;

FIG. 3 is a bottom side view of the exemplary endotracheal tube of FIG.1 in accordance with aspects of the present disclosure;

FIG. 4 is an elevational view of an exemplary endotracheal tube with afirst port located above a cuff and a second port located below the cuffin accordance with aspects of the present disclosure;

FIG. 5 is an elevational view of the distal end of the exemplaryendotracheal tube of FIG. 4 in accordance with aspects of the presentdisclosure;

FIG. 6 is a bottom side view of the exemplary endotracheal tube of FIG.4 in accordance with aspects of the present disclosure;

FIG. 7 is an elevational view of an exemplary endotracheal tube with twoports located below a cuff in accordance with aspects of the presentdisclosure; and

FIG. 8 is an elevational view of an exemplary endotracheal tube with twoports located below a cuff and one port located above the cuff inaccordance with aspects of the present disclosure.

DETAILED DESCRIPTION OF SPECIFIC EMBODIMENTS

One or more specific embodiments of the present disclosure will bedescribed below. In an effort to provide a concise description of theseembodiments, not all features of an actual implementation are describedin the specification. It should be appreciated that in the developmentof any such actual implementation, as in any engineering or designproject, numerous implementation-specific decisions must be made toachieve the developers' specific goals, such as compliance withsystem-related and business-related constraints, which may vary from oneimplementation to another. Moreover, it should be appreciated that sucha development effort might be complex and time consuming, but wouldnevertheless be a routine undertaking of design, fabrication, andmanufacture for those of ordinary skill having the benefit of thisdisclosure.

As discussed in further detail below, various embodiments of a trachealtube are provided to suction accumulated mucus secretions from theairway of intubated patients. The tracheal tube is disposable ratherthan reusable, capable of suctioning below the cuff rather thanexclusively above the cuff, capable of being used for drug delivery aswell as fluid suctioning, capable of conveying gas to and from apatient, and so forth. The disclosed embodiments include a variety ofendotracheal tubes with integral suction lumens terminating in portsoptimally located at the distal end of the endotracheal tubes between aMurphy's eye and a cuff. The ports are located sufficiently close to thecuff to disallow inadvertent contact between the suctioning ports andadjacent tissues when the cuff is inflated and the tracheal tube isplaced such that it is centered within the trachea. Furthermore, theports are located such that their openings face the posterior side ofthe patient during intubation in a conventional semirecumbent position.During intubation, the foregoing features, among others, of the trachealtube and its associated ports may have the effect of preventingbacterial colonization of the respiratory airway and the subsequentdevelopment of ventilator associated pneumonia (VAP) in the lungs.

The devices and techniques provided herein may minimize the complexityof the system used to suction mucus from the patient's airway ascompared to traditional designs because the suctioning system isintegral with the main tubular body of the tracheal tube. That is,additional assemblies need not be attached to the tracheal tubes toenable suctioning capabilities; these capabilities are inherent in thedesign and manufacture of the tracheal tubes. In certain embodiments,the provided tracheal tubes and methods of operating the tracheal tubesmay be used in conjunction with auxiliary devices, such as airwayaccessories, ventilators, humidifiers, and so forth, which may cooperatewith the tracheal tubes to maintain airflow to the patient's lungs. Forinstance, auxiliary devices may be coupled to the tracheal tubes toenable timed suctioning of the mucus such that mucus flow through thesuctioning lumen is established in the same direction and at the sametime as airflow out of the patient during expiration.

Turning now to the drawings, FIG. 1 is an elevational view of anexemplary endotracheal tube 10 in accordance with aspects of the presentdisclosure. The endotracheal tube 10 includes a central tubular body 12with proximal and distal ends 14 and 16, respectively. In theillustrated embodiment, the proximal end 14 is outfitted with aconnector 18 that may be attached to a mechanical ventilator duringoperation. The distal end 16 terminates in an opening 20 and may beplaced in a patient's trachea during operation to maintain airflow toand from the patient's lungs. A Murphy's eye 22 may be located on thetubular body 12 opposite the opening 20 to prevent airway occlusion whenthe tube assembly 10 is improperly placed within the patient's trachea.

As illustrated, a cuff 24 that may be inflated to seal against the wallsof a body cavity (e.g., a trachea) may be attached to the distal end 16of the tubular body 12. The cuff 24 may be inflated via an inflationlumen 26 terminating in an inflation tube 28 connected to a fixture 30located at the proximal end 14 of the tubular body 12. A shoulder 31 ofthe cuff 24 secures the cuff 24 to the tubular body 12. In someembodiments, the shoulder 31 may be folded up inside a lower end of thecuff 24 (not shown). As illustrated, the tubular body 12 also includes asuction lumen 32 that extends from a location on the tracheal tube 10positioned outside the body when in use to a location on the tubularbody 16 below the cuff 24 and above the Murphy's eye 22. The suctionlumen 32 terminates in a port 34 through which secretions may beaspirated. It should be noted that in further embodiments, a pluralityof ports and dedicated suction lumens may be located radially around thetubular body 12 such that secretions may be aspirated from the airwaysof patients who may be periodically repositioned during long termintubation.

An exterior suction tube 36 connects to the suction lumen 32 for theremoval of suctioned fluids. The suction tube 36 terminates outside thebody during use in a fixture 38 with a cap 40 that allows the suctiontube 36 to be connected to auxiliary equipment (e.g., vacuum, collectionreservoir, and so forth) during suctioning and to be closed when not inuse. During operation, the suction tube 36 may be connected to a vacuumthat applies suction in a predetermined continuous or discontinuousmanner such that mucus removal is synchronized with patient expiration.For instance, vacuum may be applied such that mucus flow through thesuctioning lumen 32 is established in the same direction and at the sametime as airflow out of the patient during expiration.

The tubular body 16 and the cuff 24 may be formed from materials havingdesirable mechanical properties (e.g., puncture resistance, pin holeresistance, tensile strength, and so forth) and desirable chemicalproperties (e.g., biocompatibility). In one embodiment, the walls of thecuff 24 may be made of a polyurethane (e.g., Dow Pellethane® 2363-80A)having suitable mechanical and chemical properties. In otherembodiments, the walls of the cuff 24 may be made of a suitablepolyvinyl chloride (PVC). In certain embodiments, the cuff 24 may begenerally sized and shaped as a high volume, low pressure cuff that maybe designed to be inflated to pressures between about 15 cm H₂O and 30cm H₂O.

During intubation, the endotracheal tube 10 is inserted into the tracheaof a patient such that the port 34 is located towards the posterior sideof the patient when the patient is resting in a typical semirecumbentposition. After insertion, the cuff 24 may be inflated via a syringeconnected to the inflation tube 28, thus holding the endotracheal tube10 in position. During operation, when the cuff 24 is inflated and theendotracheal tube 10 is placed such that it is centered within thetrachea, the port 34 is located sufficiently close to the cuff 24 todisallow inadvertent contact between the suctioning port 34 and theadjacent trachea. When the endotracheal tube 10 is placed in thismanner, secretions accumulating under the cuff 24 may be removed via theport 34. Additionally, when desired, the port 34, the suctioning lumen32, and the suctioning tube 36 may be used for the delivery of treatmentmodalities to the area below the cuff 24. The ability to suctionsecretions accumulated below the cuff 24 rather than exclusively abovethe cuff 24 offers distinct advantages over traditional systems. Forinstance, the port 34 below the cuff 24 allows targeting of thesecretions that may be primarily responsible for the development of VAPwith suctioning, treatment modalities, or a combination thereof

A side view of the distal end 16 of the exemplary endotracheal tube 10of FIG. 1 is shown in FIG. 2. As illustrated, the single port 34 islocated below the shoulder 31 of the cuff 24 and above the Murphy's eye22. It should be noted that the placement of the port 34 in thislocation optimizes the suctioning ability of the endotracheal tube 10.First, the single port 34 design offers advantages over devices withmultiple ports along the length of a single suctioning lumen. Forinstance, applying a vacuum to the single suctioning lumen with multipleports may result in a single port receiving all the suction (i.e., drawall of the air aspirated by the suction source), while other ports thatmay be in close proximity to accumulated mucus receive little or nosuction (i.e., draw little or no air). Second, the location of thesingle port 34 in the illustrated embodiment offers additionaladvantages over designs with ports placed in different locations. Forinstance, in traditional designs, during operation, the curvature of theendotracheal tube 10 and the operator variability associated withplacement in the patient may lead to an effective port location in closeproximity to the tracheal wall. That is, in traditional designs, it islikely that suctioning may cause the port to contact the tracheal wall,possibly causing membrane damage, occlusion of the suction lumen, andthe development of VAP due to bacterial colonization. Presentembodiments, however, may avoid these deleterious effects via placementof the port 34 in close proximity to the cuff 24, which prevents contactbetween the port 34 and adjacent body cavities.

FIG. 3 further illustrates the placement of the port 34 in a bottom sideview of the exemplary endotracheal tube 10 of FIG. 1. As illustrated,the port 34 is located such that when the endotracheal tube 10 is placedin the patient, the port 34 faces the posterior side of the patient, asrepresented by arrow 42. That is, when the endotracheal tube 10 isplaced in the patient, the port 34 is directly opposite the anteriorside of the patient, as represented by arrow 44. The port 34 isdisplaced from the center of the Murphy eye 22 by an angle 46. In theillustrated embodiment, the angle 46 is approximately 90 degrees.However, it should be noted that the particular angle 46 may bedifferent. In the illustrated embodiment, the port 34 is located on theposterior side of the patient, as indicated by arrow 42, duringoperation. For instance, the port 34 may be radially located closer toor further from the Murphy's eye 22 such that the angle 46 is decreasedor increased, respectively. Additionally, it should be noted that inother embodiments, the Murphy Eye 22 may be eliminated from the tubularbody 12. In such embodiments, an edge of the port 34 may be locatedapproximately 0 to 5 mm from an extremity of the shoulder 31. Anadvantageous radial position for the port 34 is still on the posteriorside of the patient, as represented by arrow 42, when intubated.

FIG. 4 illustrates an exemplary endotracheal tube 48 in accordance witha further embodiment of the present disclosure. As previously describedwith respect to FIG. 1, the endotracheal tube 48 includes a centraltubular body 12 with proximal and distal ends 14 and 16, respectively,wherein the proximal end 14 is outfitted with a connector 18 that may beattached to a mechanical ventilator during operation. The distal end 16terminates in an opening 20 and may be placed in a patient's tracheaduring operation to maintain airflow to and from the patient's lungs. AMurphy's eye 22 may be located on the tubular body 12 opposite theopening 20 to prevent airway occlusion when the tube assembly 10 isimproperly placed within the patient's trachea. The inflatable cuff 24may be inflated via the inflation lumen 26 terminating in the inflationtube 28 connected to the fixture 30 located at the proximal end 18 ofthe tubular body 12. The shoulder 31 of the cuff 24 secures the cuff 24to the tubular body 12. In some embodiments, the shoulder 31 may befolded up inside a lower end of the cuff 24 (not shown).

As in the embodiment of FIG. 1, the embodiment illustrated in FIG. 4 mayinclude the suction lumen 32 that extends from a location on thetracheal tube 48 positioned outside the patient when in use to alocation on the tubular body 16 below the cuff 24 and above the Murphy'seye 22. As before, the suction lumen 32 may terminate in a port 34through which secretions located below the cuff 24 may be aspirated. Itshould be noted that in further embodiments, a plurality of ports anddedicated suction lumens may be located radially around the tubular body12 such that secretions may be aspirated from the airways of patientswho may be periodically repositioned during long term intubation.However, the embodiment of FIG. 4 also includes an additional suctionlumen 50 that extends from near the proximal end 14 of the tubular body12 positioned outside the patient when in use to a location adjacent toand above the cuff 24. The additional suction lumen 50 may terminate inan additional port 52 through which secretions located above the cuff 24may be aspirated. Suction tubes 36 and 54 connect to suction lumens 32and 50, respectively, for the removal of fluids suctioned through theports 34 and 52. The suction tubes 36 and 54 terminate in fixtures 38and 56 with caps 40 and 58 that allow the suction tubes 36 and 54 to beconnected to auxiliary equipment (e.g., vacuum, collection reservoir,and so forth) during suctioning and to be closed when not in use.

The suction tubes 36 and 54 may be connected to a vacuum that appliessuction in a predetermined continuous or discontinuous manner such thatmucus removal is synchronized with patient expiration and/or coordinatedbetween the two ports 34 and 52. For instance, as in previousembodiments, vacuum may be applied such that mucus flow through thesuctioning lumens 32 and 50 is established in the same direction and atthe same time as airflow out of the patient during expiration.Additionally, in this embodiment, vacuum may be applied such thatalternating ports 34 or 52 are activated during each patient expirationcycle, both ports 34, 52 are activated during each respiration cycle,one or both ports 34 and/or 52 is manually selected by a caregiverduring each respiration cycle, and so forth.

During intubation, the endotracheal tube 48 is inserted into the tracheaof a patient such that the ports 34, 52 are located towards theposterior side of the patient when the patient is resting in the typicalsemirecumbent position. After insertion, the cuff 24 may be inflated viaa syringe connected to the inflation tube 28, thus holding theendotracheal tube 48 in position. During operation, when the cuff 24 isinflated and the endotracheal tube 48 is placed such that it is centeredwithin the trachea, the ports 34, 54 are located sufficiently close tothe cuff 24 to disallow inadvertent contact between the suctioning ports34, 54 and the adjacent trachea. When the endotracheal tube 10 is placedin this manner, secretions accumulating under the cuff 24 may be removedvia the port 34, and secretions accumulating above the cuff 24 may beremoved via the port 54. The port 34 located below the cuff, thesuctioning lumen 32, and the suctioning tube 36 may be used for thedelivery of treatment modalities to the area below the cuff 24 whendesired. Similarly, the port 54 located above the cuff 24, thesuctioning lumen 50, and the suctioning tube 54 may be used for thedelivery of treatment modalities to the area above the cuff 24 whendesired.

A side view of the distal end 16 of the exemplary endotracheal tube 48of FIG. 4 is shown in FIG. 5. As illustrated, the port 34 below the cuff24 is located below the shoulder 31 of the cuff 24 and above theMurphy's eye 22, whereas the port 52 above the cuff 24 is adjacent tothe top of the cuff 24. It should be noted that the placement of theports 34, 52 and the inclusion of a separate lumen 32 or 50 for eachport 34 or 52 optimizes the suctioning ability of the endotracheal tube48. As previously mentioned, traditional designs may apply a vacuum to asingle suctioning lumen with multiple ports, possibly resulting in asingle port receiving all the suction while other ports that may be inclose proximity to accumulated mucus receive little or no suction. Thepresent disclosure may overcome this disadvantage since each port 34 or52 is exclusively connected to its designated suction lumen 32 or 50.Additionally, the location of the ports 34, 52 in the illustratedembodiment offers further advantages over traditional designs. In suchdesigns, it is likely that suctioning may cause the ports to contact thetracheal wall, possibly causing membrane damage, occlusion of thesuction lumen, and the development of VAP due to bacterial colonization.Present embodiments, however, may avoid these deleterious effects duringoperation via placement of the ports 34, 52 in close proximity to thecuff 24, which prevents contact between the port 34 and adjacent tissueswhen inflated.

FIG. 6 further illustrates the placement of the ports 34, 52 in a bottomside view of the exemplary endotracheal tube 48 of FIG. 4. Asillustrated, the ports 34, 52 are located such that when theendotracheal tube 48 is placed in the patient, the ports 34, 52 face theposterior side of the patient, as represented by arrow 42. That is, whenthe endotracheal tube 10 is placed in the patient, the ports 34, 52 aredirectly opposite the anterior side of the patient, as represented byarrow 44. The port 34 below the cuff 24 and the port 52 above the cuff24 are displaced from the center of the Murphy's eye 22 by angles 60 and62, respectively. In the illustrated embodiment, the angles 60, 62 areapproximately 90 degrees. However, it should be noted that the angles60, 62 may be any measure such that the ports 34, 52 are located on theposterior side of the patient, as indicated by arrow 42, duringoperation.

FIGS. 7 and 8 illustrate further embodiments of the endotracheal tubes10, 48 disclosed in FIGS. 1 and 4, respectively. Exemplary endotrachealtubes 64, 66 are provided that include an additional lumen 68 thatterminates below the cuff 24 in an additional port 70. The lumen 68 maybe configured to cooperate with pressure sensors and/or pressureindicators that may be placed in locations along the lumen 66. Duringoperation, the lumen 68 may extend to a location outside of the airwayof the patient, possibly terminating in an inflation indicator that theoperator may use to determine proper inflation of the cuff 24. In someembodiments, the lumen 68 may terminate in a pressure sensor that isconfigured to sense the pressure of the cuff 24.

While the disclosure may be susceptible to various modifications andalternative forms, specific embodiments have been shown by way ofexample in the drawings and have been described in detail herein.However, it should be understood that the embodiments provided hereinare not intended to be limited to the particular forms disclosed.Rather, the various embodiments may cover all modifications,equivalents, and alternatives falling within the spirit and scope of thedisclosure as defined by the following appended claims.

What is claimed is:
 1. A tracheal tube, comprising: a tubular bodycomprising an open distal end for ventilating a patient and a Murphy'seye adjacent to the open distal end on an exterior side wall of thetubular body; a cuff disposed around the tubular body and configured tobe inflated to seal the cuff against a wall of a patient's trachea; afirst suction port disposed on the exterior side wall of the tubularbody at a fixed location below the cuff and above the open distal end,wherein the first suction port is radially displaced from the Murphy'seye by a first angle, and wherein the first suction port is the distalmost suction port of a first suction lumen; and a second suction portdisposed on the exterior side wall of the tubular body proximal of thefirst suction port.
 2. The tracheal tube of claim 1, wherein the firstangle, the second angle, or both is approximately 90 degrees.
 3. Thetracheal tube of claim 1, comprising a pressure monitoring lumenextending along the tubular body adjacent to the first suction lumen andthe second suction lumen, wherein the pressure monitoring lumenterminates in a port disposed on the side of the tubular body that isopposite the open distal end, and wherein the port is below the cuff. 4.The tracheal tube of claim 1, wherein the second suction port is thedistal most suction port of a second suction lumen that is separate fromthe first suction lumen.
 5. The tracheal tube of claim 1, wherein thecuff comprises a shoulder and the fixed location of the first suctionport is located between the shoulder and the Murphy's eye.
 6. Thetracheal tube of claim 1, wherein the second suction port is locatedabove the cuff.
 7. The tracheal tube of claim 1, wherein the firstsuction port is configured to deliver one or more treatment modalitiesto the area below the cuff.
 8. The tracheal tube of claim 1, wherein thefirst suction port and the second suction port are disposed on a side ofthe tubular body that is oriented posteriorly following intubation ofthe patient.
 9. The tracheal tube of claim 1, comprising a vacuum sourcecoupled to the first and the second suction lumens and configured toapply suction to the first and the second suction lumens to aspiratesecretions through the first and the second suction ports, respectively.10. The tracheal tube of claim 9, wherein the vacuum source isconfigured to apply suction to the first suction lumen, the secondsuction lumen, or both during patient expiration and to not applysuction to the first and the second suction lumens during patientinspiration.
 11. A tracheal tube, comprising: a tubular body comprisingan open distal end for ventilating a patient and a Murphy's eye adjacentto the open distal end on an exterior side wall of the tubular body; acuff disposed around the tubular body and configured to be inflated toseal the cuff against a wall of a patient's trachea; a first suctionport disposed on the exterior side wall of the tubular body at a fixedlocation below the cuff and above the open distal end, wherein thelocation is between approximately 0 and approximately 5 millimetersbelow the cuff, wherein the first suction port is radially displacedfrom the Murphy's eye by a first angle, and wherein the first suctionport is the distal most suction port of a first suction lumen; and asecond suction port disposed on the exterior side wall of the tubularbody proximal of the first suction port, wherein the second suction portis at a fixed location approximately 0 and approximately 5 millimetersabove the cuff.
 12. The tracheal tube of claim 11, wherein the firstangle, the second angle, or both is approximately 90 degrees.
 13. Thetracheal tube of claim 11, comprising a pressure monitoring lumenextending along the tubular body adjacent to the first suction lumen andthe second suction lumen, wherein the pressure monitoring lumenterminates in a port disposed on the side of the tubular body that isopposite the open distal end, and wherein the port is below the cuff.14. The tracheal tube of claim 11, wherein the second suction port isthe distal most suction port of a second suction lumen that is separatefrom the first suction lumen.
 15. The tracheal tube of claim 11, whereinthe cuff comprises a shoulder and the fixed location of the firstsuction port is located between the shoulder and the Murphy's eye. 16.The tracheal tube of claim 11, wherein the first suction port isconfigured to deliver one or more treatment modalities to the area belowthe cuff.
 17. The tracheal tube of claim 11, wherein the second suctionport is configured to deliver one or more treatment modalities to thearea above the cuff.
 18. The tracheal tube of claim 11, wherein thefirst suction port and the second suction port are disposed on a side ofthe tubular body that is oriented posteriorly following intubation ofthe patient.
 19. The tracheal tube of claim 1, comprising a vacuumsource coupled to the first and the second suction lumens and configuredto apply suction to the first and the second suction lumens to aspiratesecretions through the first and the second suction ports, respectively.20. The tracheal tube of claim 19, wherein the vacuum source isconfigured to apply suction to the first suction lumen, the secondsuction lumen, or both during patient expiration and to not applysuction to the first and the second suction lumens during patientinspiration.